Validation & Qualification

How do you guarantee that your products meet quality demands and comply with regulations? Through validation & qualification of your processes, equipment and software. Risk-based validation & qualification is the adequate method to prove your product is correctly prepared, packaged, labelled and transported. That’s why each quality control process in the life sciences, healthcare and cosmetics industries needs to contain a certain validation & qualification aspect.

QbD offers an extensive range of validation & qualification services:

Our risk-based validation & qualification approach

For many organizations, being compliant often results in a costly and time-consuming venture. That’s why we implemented a risk-based validation & qualification approach in all our related services. This pragmatic approach – based on industry best practices like Science Based Risk Management (GAMP 5 ® (ISPE)) – helps us to focus on product quality and patient safety, while reducing the cost of validation & qualification. In other words, it focuses on what really matters.

Equipment Validation & qualification

Our equipment validation & qualification method ensures equipment compliance: a high degree of assurance that equipment consistently produces a result or a product that meets its predetermined and required specifications.

By validating equipment – like (bio)reactors, autoclaves and packaging machines – companies guarantee the optimum quality, safety and compliance of their products. The validation & qualification of equipment consists of various stages, including writing down equipment specifications, carrying out a risk analysis, testing possible risks, documenting test evidence and monitoring.

Equipment validation & qualification is a time-consuming process. Every significant change to equipment, which may affect the quality of its result, should be validated. Companies face difficulties like a lack of experience or the absence of proper estimation of all the risks of specific equipment. QbD has an extensive range of equipment validation & qualification services to guarantee optimal equipment compliance.

Process Validation & Qualification

During process validation & qualification, you analyze product data – collected during the design and manufacturing process – to confirm that your process reliably delivers products of a certain standard. This applies to various processes, including cleaning, packaging, filling and formulation processes.

The purpose is to ensure that varied inputs lead to a consistent and high-quality output or product, complying with the process validation & qualification guidelines from authorities like the Food & Drug Administration (FDA) and the European Medicine Agency (EMA). End-to-end validation & qualification of processes is crucial to determine product quality, because inspection of finished products cannot always determine quality.

Process validation & qualification is an ongoing process which you must frequently adapt to manufacturing feedback. Fortunately, our validation & qualification experts are pleased to set up, improve and support the validation & qualification of your processes. Thanks to a risk-based validation & qualification approach, they help you develop and implement a strategy to optimize product quality and minimize compliancy costs.

Computer System Validation

Computer System Validation is a discipline on its own. It provides the users with evidence and assurance that data coming from these systems are consistent and reliable.

Customized validation & qualification services

There are no golden rules when it comes to exact methods for validation & qualification. Each company deals with legal compliance in its own way. QbD supports every validation & qualification process with customized services based on international regulations.

Our validation & qualification experts have the risk-based validation & qualification approach built into their genes. Thanks to a combination of best practices, extensive knowledge of processes and close collaboration with your team, they work in an efficient and well-structured way. The result? You save time, increase efficiency and lower your total compliance costs.

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If you have any questions or need additional information on our services, please feel free to contact us.